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Quality & compliance

Our SOPs are written to survive inspection, not to pass one. Here is what that means in practice.

Regulatory

Every product, a documented pathway

Nothing moves through HAC Pharma without a regulatory file behind it. Our in-house team owns the dossier from first submission to post-approval variation, and maintains establishment and product licences so that a registration never lapses quietly.

  • SFDA registrationProduct, establishment and licence files maintained current.
  • GCC & WHO alignmentSubmissions structured to regional and international standards.
  • Good Distribution PracticeValidated SOPs, deviation handling and CAPA.
  • Full traceabilityBatch-level records from manufacturer to practitioner.
Saudi regulatory and government bodies
Storage

Three temperature bands, separately validated

Ambient, chilled and frozen stock sit in dedicated zones under continuous electronic monitoring, with automated excursion alerts and backup power. Every pallet carries a traceable record from goods-in to final delivery note.

AmbientGeneral pharmaceuticals, devices and supplements.
+15 °C to +25 °C
ChilledBiologicals, vaccines, insulin and temperature-sensitive lines.
+2 °C to +8 °C
FrozenDeep-cold products under validated thermal packaging.
−20 °C
Pharmaceutical warehouse
Cold chain transport
Transport

Cold chain that holds to the last mile

GPS-tracked refrigerated vehicles maintain temperature control across the Kingdom, supported by phase-change materials and vacuum-insulated packaging that protect product on both long-haul and last-mile legs.

Excursions are the risk that ends partnerships. Ours are monitored continuously, alerted automatically, investigated under a defined deviation procedure, and closed out in writing.

Read the market entry brief →

Ask us for the documents.

Establishment licence, commercial registration, VAT certificate and Chamber membership — available to serious partners on request.

Talk to us Company profile (PDF)